FSP Manager – Senior Manager Clinical Operations

This is a fully remote position, open to applicants in Germany.

📋 Description

• Supervise, train, allocate resources, coach, and manage the performance of clinical operations staff.

• Drive team performance using metrics and key performance indicators.

• Serve as an escalation point for performance issues and training requirements.

• Partner with leadership to address resourcing needs.

• Manage staff through coaching, mentorship, work direction, evaluations, career discussions, recruitment, and selection processes.

• Oversee induction and orientation programs for new hires.

• Maintain records of staff CVs, training documentation, position descriptions, and experience profiles.

• Ensure the timely submission of accurate timesheets and expense reports.

• Assist with local resource allocation and project/functional leadership activities.

• Identify potential issues that may impact project deliverables.

• Provide training on WPDs, SOPs, local requirements, and clinical operations.

• Recognize training gaps and ensure that training needs are fulfilled.

• Ensure compliance with ethical and regulatory standards.

• Notify management of quality issues and facilitate quality assurance audits.

• Review systems such as Activate, CTMS, Preclarus, and Clarity to assess employee/project metrics, KPIs, and project status.

• Conduct remote or on-site PAVs to evaluate monitoring skills and project execution.

• Engage in process improvement and development initiatives.

• Ensure comprehension and implementation of risk-based monitoring.

• Contribute to bids and procurement processes for new business as necessary.

• Collaborate with senior management and executive staff on strategic planning and business development.

• Lead or participate in initiatives aimed at enhancing departmental and company performance.

⛳️ Requirements

• Prior experience providing the knowledge, skills, and abilities necessary for the role, equivalent to 5+ years.

• At least 2-3 years of leadership or line management experience.

• Full authorization to work in Germany.

• Proficiency in both German and English (C1 level); interviews will be conducted in both languages.

• Consideration for equivalency through an appropriate combination of education, training, and/or directly related experience may apply.

• Advanced mentoring, leadership, and supervisory capabilities.

• Exceptional clinical trials monitoring skills, both remotely and on-site.

• Ability to learn and implement SOPs, WPDs, ICH/GCP, and FDA guidelines.

• Competence in evaluating medical research data.

• Strong organizational, negotiation, and attention-to-detail skills.

• Excellent written and verbal communication skills.

• Proficient in computer operations, including data entry, archiving, and retrieval.

• Willingness to travel as necessary.

• Skills in team building, interpersonal communication, and conflict resolution.

• Problem-solving abilities in dynamic environments.

• Knowledge of medical/therapeutic areas and medical terminology.

• Experience with FSP is preferred.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and professional development.

• Chance to contribute to scientific excellence and innovation.